Background: We aimed to examine whether using a high fraction of inspired oxygen (FIO 2 ) in the context of an individualised intra-and postoperative open-lung ventilation approach could decrease surgical site infection (SSI) in patients scheduled for abdominal surgery. Methods: We performed a multicentre, randomised controlled clinical trial in a network of 21 university hospitals from June 6, 2017 to July 19, 2018. Patients undergoing abdominal surgery were randomly assigned to receive a high (0.80) or conventional (0.3) FIO 2 during the intraoperative period and during the first 3 postoperative hours. All patients were mechanically ventilated with an open-lung strategy, which included recruitment manoeuvres and individualised positive end-expiratory pressure for the best respiratory-system compliance, and individualised continuous postoperative airway pressure for adequate peripheral oxyhaemoglobin saturation. The primary outcome was the prevalence of SSI within the first 7 postoperative days. The secondary outcomes were composites of systemic complications, length of intensive care and hospital stay, and 6-month mortality. Results: We enrolled 740 subjects: 371 in the high FIO 2 group and 369 in the low FIO 2 group. Data from 717 subjects were available for final analysis. The rate of SSI during the first postoperative week did not differ between high (8.9%) and low (9.4%) FIO 2 groups (relative risk [RR]: 0.94; 95% confidence interval [CI]: 0.59e1.50; P¼0.90]). Secondary outcomes, such as atelectasis (7.7% vs 9.8%; RR: 0.77; 95% CI: 0.48e1.25; P¼0.38) and myocardial ischaemia (0.6% [n¼2] vs 0% [n¼0]; P¼0.47) did not differ between groups. Conclusions: An oxygenation strategy using high FIO 2 compared with conventional FIO 2 did not reduce postoperative SSIs in abdominal surgery. No differences in secondary outcomes or adverse events were found. Clinical trial registration: NCT02776046.
Fundamento. La infección de localización quirúrgica (ILQ) tiene un considerable impacto clínico y económico a nivel hospitalario, por lo que se consideran prioritarios su prevención y seguimiento. El objetivo de este estudio fue la evaluación del cumplimiento del protocolo de profilaxis antibiótica en la cirugía de colon y el efecto de su inadecuación en la incidencia de ILQ. Material y métodos. Se realizó un estudio de cohortes prospectivo desde julio de 2008 a julio de 2016. Se evaluó el grado de cumplimiento de la profilaxis antibiótica y las causas de incumplimiento en cirugía de colon: duración e inicio, elección, vía de administración y dosis de antibiótico. Se estudió la incidencia de ILQ después de un período máximo de incubación de 30 días. Para evaluar el efecto del incumplimiento de la profilaxis en la ILQ se usó el riesgo relativo (RR). resultados. El estudio incluyó 771 pacientes. La incidencia acumulada de ILQ fue del 5,8%, la mayoría (67%) infecciones incisionales superficiales. La etiología más frecuente de ILQ fue Escherichia coli (28%). La profilaxis antibiótica se administró en el 97,8% de los pacientes, con un cumplimiento global del protocolo del 91,9%. La causa principal de incumplimiento fue la elección del antibiótico (58,2%). No se encontró relación entre inadecuación de la profilaxis e incidencia de infección de localización quirúrgica (RR=0,5; IC 95% 0,1-1,8). conclusiones. La tasa global de adecuación al protocolo de profilaxis antibiótica fue alta. No se encontró asociación significativa entre adecuación de la profilaxis e incidencia de ILQ en cirugía de colon. Palabras clave. Profilaxis antibiótica. Infección de localización quirúrgica. Cirugía de colon. Incidencia. Vigilancia epidemiológica.
aBstractBackground. Surgical site infection (SSI) has a considerable clinical and economic impact at the hospital level, so prevention and monitoring are considered a high priority. The objective of this study was to assess compliance with the protocol of antibiotic prophylaxis in colon surgery and the effect of its inadequacy for the incidence of SSI. Methods. Prospective cohort study from July 2008 to July 2016. Compliance with antibiotic prophylaxis protocol and the causes of non-compliance were evaluated in colon surgery: duration and starting, choice, route of administration and dose of the antibiotic. The incidence of SSI was studied after a maximum incubation period of 30 days. Relative risk (RR) was used to evaluate the non-compliance causes of prophylaxis. results. The study included 771 patients. The cumulative incidence of SSI was 5.8% (n=45), of which 2/3 were superficial incisional infections. The most common cause of SSI was Escherichia coli (28%). Antibiotic prophylaxis was administered in 97.8% of patients, with an overall protocol compliance of 91.9%. The principle cause of non-compliance was the choice of antibiotic (58.2%). No relationship between the inadequacy of prophylaxis and incidence of surgical site infection was found (RR=0.5; CI 95% 0.1-1.8). conclusions. The overal...
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